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FDA Links -- About CDER/FDA News
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FDA Drug Safety Communication:
Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of
Tysabri (natalizumab)
(2/5/2010)
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FDA approves Xiaflex (collagenase clostridium histolyticum) for
debilitating hand condition (2/3/2010)
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First-Time Generics - December 2009 (Updated: 2/3/2010)
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Postmarket Requirements and Commitments Database
(updated 2/2/2010)
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MedWatch Alert - Zyprexa (olanzapine): Use
in Adolescents
(2/1/2010)
- FDA issued a Drug Safety
Communication:
Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
(1/29/2010)
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Initiatives (Center for Drug Evaluation and Research) (1/28/2010)
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MedWatch Alert - Velcade (bortezomib):
Starting Dose Adjustments for Patients with Hepatic Impairment
(1/26/2010)
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FDA approves Ampyra (dalfampridine) extended
release tablets to improve walking in adults with multiple sclerosis
(1/25/2010)
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UPDATED Public Health Alert: Counterfeit Alli containing
sibutramine (1/22/2010)
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MedWatch Alert: Alli 60 mg capsules (120
count refill kit): Counterfeit product (1/19/2010)
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The Adverse Event Reporting System (AERS): Latest
Quarterly Data Files (updated
1/19/2010)
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Field Correction of Influenza A (H1N1) 2009 Monovalent
Vaccine Live, Intranasal Expiration Dating (Posted: 1/15/2010)
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PREA Retrospective Review (PDF - 281KB) (1/14/2009)
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Follow-Up to the October 2008 Updated Early Communication about an
Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)
(1/14/2009)
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Fast Track Designation Request Performance (Updated: 1/12/2009)
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MedWatch Alert - Rapamune (sirolimus):
Drug Monitoring Recommendations (1/11/2010)
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Presentations from Public Hearing on Promotion of
FDA-Regulated Medical Products Using the Internet and Social Media Tools
(November 12-13, 2009)
(Posted 12/31/2009)
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FDA, Health Organizations to Study Safety of
Medications Taken During Pregnancy (12/31/2009)
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MedWatch Alert: Tylenol Arthritis Pain Caplet, 100 count
bottles - Recall of all lots (Updated:
12/29/2009)
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Follow-Up to the August 2008 Early
Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin
(marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe
(marketed as Zetia) - FDA Investigates a Report from the SEAS Trial
(12/22/2009)
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Information for Healthcare Professionals
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Mandatory Adverse Event Reporting for Emergency Use of Peramivir IV
Under EUA (updated 12/18/2009)
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Drug Safety Oversight Board Meeting, Public Summary, November 16, 2009
(12/16/2009)
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Public Health Advisory: Availability of
Tamiflu for Oral Suspension (12/14/2009)
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December 15, 2009: Vaccines and Related Biological
Products Advisory Committee Briefing Documents
Roster and Draft Agenda posted (Posted: 12/11/2009)
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New Drug Review: 2009 Update, presentation by John K.
Jenkins, M.D. Director, Office of New Drugs (PDF - 514 KB)
(12/10/2009)
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MedWatch Alert: Alka-Seltzer Plus Day &
Night Cold Formula Liquid Gels - Incorrect Packaging (12/10/2009)
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Positron Emission Tomography (PET)
(Updated 12/9/2009)
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Prescription Drug User Fee Act: FY 2009 Clean-up Product and
Establishment Fee Invoices were mailed on 12/9/2009 (Updated
12/9/2009)
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Approved Risk Evaluation and Mitigation Strategies (REMS)
(updated 12/8/2009)
- Manual of Policies and Procedures (MaPP)
4657.3 (PDF - 217 KB) Overtime Policy
(updated 12/8/2009)
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MedWatch Alert: Voltaren Gel (diclofenac
sodium topical gel) 1% - Hepatic Effects Labeling Changes (12/8/2009)
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FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks
of Hereditary Angioedema
(12/3/2009)
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FDA Drug Safety Newsletter - Volume 2, Number 3, 2009 (12/3/2009)
- Information for Healthcare
Professionals:
Risk of Neural Tube Birth Defects following prenatal exposure to
Valproate (12/3/2009)
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MedWatch Alert for Norpramin (desipramine
hydrochloride) (12/2/2009)
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FDA’s Woodcock Discusses Pain Management and
Drug Safety in Nov. 26, 2009 Issue of The New England Journal of
Medicine
(11/30/2009)
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Approved Active Moieties That Have Appeared On The
National Institutes Of Health’s (NIH) Annual Priority List For Which FDA
Has Issued A Written Request For Pediatric Studies Under The Best
Pharmaceuticals For Children Act (BPCA)
(updated
11/27/2009)
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Early Communication about an Ongoing Safety
Review of Meridia (sibutramine hydrochloride) (11/20/2009)
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Information for Healthcare Professionals: Peramivir IV
Renal Dosing Recommendations
(11/20/2009)
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MedWatch Safety Alert: Vicks Sinex Nasal Spray - Recall
(11/20/2009)
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Opioid Drugs and Risk Evaluation and Mitigation
Strategies (REMS) (updated
11/20/2009)
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Drug Safety Oversight Board Meeting, Public
Summary, October 15, 2009 (11/19/2009)
- Information for Healthcare Professionals
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Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to
alert healthcare professionals about a drug interaction with omeprazole
(marketed as Prilosec and Prilosec OTC) (11/17/2009)
- Follow-Up
to the January 26, 2009, Early Communication about an Ongoing Safety
Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole
(marketed as Prilosec and Prilosec OTC) (11/17/2009)
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Public Health Advisory: Updated Safety Information about
a drug interaction between Clopidogrel Bisulfate (marketed as Plavix)
and Omeprazole (marketed as Prilosec and Prilosec OTC) (11/17/2009)
- Pediatric Drug Development:
Breakdown of FDAAA Completed Pediatric Studies (Updated:
11/16/2009)
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FDA approves Istodax (romidepsin) for treatment of
patients with a rare form of cancer known as Cutaneous T-cell Lymphoma
(11/10/2009)
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MedWatch Alert: Hospira Brand Propofol and Liposyn
Products - Recall (11/10/2009)
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MedWatch Alert: Stiff Nights - product contains
undeclared drug ingredient (11/6/2009)
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MedWatch Alert: Ketorolac Tromethamine Injection, USP 30
mg/mL; 1mL and 2mL Single Dose Vials -- Recall
(11/6/2009)
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MedWatch Alert: Bodybuilding.com Brand Dietary
Supplements - Sold on Internet (11/6/2009)
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Rulemaking History for Nonprescription
Products: Labeling (11/6/2009)
- Public Hearing on Promotion of
FDA-Regulated Medical Products Using the Internet and Social Media
Tools. Registration for this Nov. 14-15 meeting is closed. A free
webcast will be available, no registration necessary.
Webcast information (11/5/2009)
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FDA Unveils Safe Use Initiative that Targets Preventable
Harm from Medication Use (11/4/2009)
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Information for Healthcare
Professionals:
Reports of Altered Kidney Function in patients using Exenatide (Marketed
as Byetta) (11/2/2009)
- CDER Manual of Policies and Procedures (MaPP) (Updated11/2/2009)
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4300.1 CDER Medical Policy
Coordinating Committee
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5120.1R Office of Clinical
Pharmacology Briefing Criteria and Attendance Policies
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MedWatch Alert on Rituxan (rituximab) and
progressive multifocal leukoencephalopathy (PML)
(10/26/2009)
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Information for Healthcare Professionals - Mandatory Adverse Event
Reporting for Emergency Use of Peramivir Under EUA (10/23/2009)
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Approved Risk Evaluation and Mitigation Strategies (REMS)
(updated 10/22/2009)
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